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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00652470
Other study ID # 1000007601
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date September 2005
Est. completion date May 1, 2018

Study information

Verified date September 2018
Source The Hospital for Sick Children
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to study whether infants with triventricular hydrocephalus (TVH) have a better long-term outcome at 5 years when they are treated with a new procedure, endoscopic third ventriculostomy (ETV), than infants treated with the more traditional treatment, insertion of a cerebrospinal fluid (CSF) shunt.


Description:

TVH is a relatively uncommon condition in infants, in which CSF accumulates in the brain's ventricles due to a blockage in outflow at the level of cerebral aqueduct. This can cause increased intracranial pressure, with adverse effect on brain development. The causes of this include congenital aqueductal stensois or acquired aqueductal stenosis from previous brain hemorrhage or infection.

TVH is currently treated through one of the following two approaches:

- Extra-cranial CSF diversion through ventricular shunts. Extra-cranial shunting has been the standard approach over the past few decades, since functional shunts were first developed and inserted successfully.

- Intra-cranial internal CSF diversion using endoscopic techniques. The principles of internal diversion were clear from the time neurosurgeons first understood the nature of hydrocephalus. However, internal diversion was never really practical or successful on a large scale until the more recent development of neuroendoscopy. There is currently a revived interest in diversionary hydrocephalus treatment through neuroendoscopic surgical techniques, with the primary focus on endoscopic third ventriculostomy (ETV).


Recruitment information / eligibility

Status Completed
Enrollment 182
Est. completion date May 1, 2018
Est. primary completion date May 1, 2018
Accepts healthy volunteers No
Gender All
Age group N/A to 24 Months
Eligibility Inclusion Criteria:

- Symptomatic TVH requiring treatment.

- No previous treatment for TVH

- Under 24 months of age at time of surgery

- Full-term pregnancy (>36 weeks)

- Mandatory pre-operative MRI that includes mid-sagittal T1 & T2 scans which show: Tri-ventricular pattern of hydrocephalus; proof of no flow through aqueduct; presence of CSF collection over the convexity and/or inter-hemispheric fissure is acceptable; configuration of third ventricle floor could vary; deformed tectal plate is acceptable; posterior fossa fluid collections may be included as long as: aqueduct is closed; vermis preserved (complete Dandy Walker Syndrome excluded); questionable flow in aqueduct acceptable as long as TVH exists

- History or suggestion of intra-ventricular bleed (intra-uterine or post-natal) or intracranial infection qualifies (excluding intraventricular hemorrhage of prematurity).

- Ability to participate in followup for at least 5 years

Exclusion Criteria:

- Open Spina Bifida

- Complete Dandy Walker syndrome (vermian agenesis / dysgenesis)

- Prematurity

- Perinatal asphyxia

- Severe dysmorphic anatomical features or known chromos (e.g. agenesis of corpus callosum, heterotopias, large cysts)

- intracranial tumor

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Endoscopic Third Ventriculostomy
A standard frontal burr hole will be made and an endoscopic camera used to visualize the floor of the third ventricle. A ventriculostomy will be created in the floor of the third using the surgeon's own preferred method of perforation.
CSF Shunt Insertion
The procedure involves creating a burr hole in the frontal or occipital regions and cannulating the ventricle with a silastic catheter. This is then attached to a valve mechanism and distal silastic tubing which runs subcutaneously in the peritoneal cavity.

Locations

Country Name City State
Argentina Nacional de Pediatria Buenos Aires
Brazil Biocor Instituto Nova Lima
Brazil UNIFESP Sao Paulo
Canada The Hospital for Sick Children Toronto Ontario
Germany University Hospital Gießen and Marburg Giessen
Hungary University of Debrecen Debrecen
India Sanjay Gandhi Postgraduate Institute of Medical Sciences Lucknow
India All India Institute of Medical Sciences New Delhi
Israel Dana Children's Hospital, Tel Aviv Medical Center Tel Aviv
Italy Giannina Gaslini Hospital Genova
Italy Catholic University Medical School Rome Rome
Netherlands University Medical Center St Radboud Nijmegen
Poland Medical University of Silesia Katowice
Poland Polish Mother's Memorial Hospital Lodz
Poland Children's Memorial Health Institute Warsaw
Russian Federation Burdenko Neurosurgical Institute Moscow
Serbia Institute for Neurosurgery Belgrade
Spain Hospital Sant Joan de Deu Barcelona
Turkey Hacettepe University Hospital Ankara
United Kingdom Birmingham Children's Hospital Birmingham
United Kingdom Alder Hey Children's Hospital Liverpool
United States Children's Medical Center of Dallas Dallas Texas

Sponsors (3)

Lead Sponsor Collaborator
The Hospital for Sick Children The International Society for Pediatric Neurosurgery, The International Study Group for Neuroendoscopy (ISGNE)

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  Canada,  Germany,  Hungary,  India,  Israel,  Italy,  Netherlands,  Poland,  Russian Federation,  Serbia,  Spain,  Turkey,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Health Status Outcome as measured by the Health Utilities Index - 2 At 5 years of age
Secondary Death Duration of the Study
Secondary Neurodevelopment as measured by the Denver Developmental Screening Test Up to 3 years of Age
Secondary Health status outcome using the Hydrocephalus Outcome Questionnaire At 5 years of Age
Secondary In-depth Evaluation of Neurodevelopment, Functioning and Intelligence, as mesured by the Weschler Intelligence Scale for Children or Weschler Preschool and Primary Scale of Intelligence At 5 years of Age
Secondary Number of Subsequent Hydrocephalus-Related Operations Duration of the Study
Secondary Surgical Morbidity Duration of the Study
Secondary Incidence of failure of initial intervention Duration of the Study
Secondary Hospitalization Time 5 years post-operation
Secondary Need for repeat radiological scans Duration of the Study
Secondary Complications such as CNS infection, focal neurological deficit, significant hemorrhage, seizures requiring medication Duration of the Study
Secondary Ventricular size and the existence of flow void (ETV group)assessed through radiological evaluation 3 years of age
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